Hypertension Induced by PregnancyNCT01669525
Placental Growth and Adverse Pregnancy Outcomes
An observational study of Hypertension Induced by Pregnancy and Pre-Eclampsia, run by University of Pennsylvania at 1 site in United States.
Trial summary
The purpose of this study to determine if measurement of maternal serum biomarkers and evaluation of the placenta by ultrasound can improve prediction of adverse pregnancy outcomes. Read more about this study
- Who is it for?
- Any age, women onlyHealthy volunteers can take part
- Conditions the study is for
- Hypertension Induced by Pregnancy, Pre-Eclampsia, IUGR
- How many people
- 1,043 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2009to Jun 2016
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- Women only
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Singleton pregnancies presenting for Sequential Screen prior to 14 weeks gestation
Who may be able to join
- All singleton gestations presenting for Sequential Screen testing at HUP
- patients competent to provide verbal informed consent
Who cannot join
- Multiple gestations
- patients not competent to provide informed consent
- patients found to be too late for the Sequential Screen
- pregnancy losses 20 weeks gestation
- major fetal anomalies
- patient delivering outside of the UPHS
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Pennsylvania Health System
Philadelphia, Pennsylvania, 19104
About this study
Official title: Placental Growth and Maternal Serum Biomarkers in the Prediction of Adverse Pregnancy Outcome
The purpose of this study to determine if measurement of maternal serum biomarkers and evaluation of the placenta by ultrasound can improve prediction of adverse pregnancy outcomes.
Read the detailed description
The placenta is known to play a vital role in maintaining a healthy pregnancy. Placental dysfunction is believed to be a driving factor in a variety of adverse obstetric outcomes, including fetal growth restriction and preeclampsia. Advances in 3D ultrasound have allowed for measurement of placental volumes during pregnancy. It may be that quantitative assessment of early placental growth can help identify pregnancies at risk for adverse outcome. Furthermore, various novel serum analytes have been proposed as predictors of adverse outcome. The investigators seek to prospectively measure placental volume and diameter at 11-14 weeks and 18-24 weeks to determine if placental growth can predict adverse outcome. In addition, the investigators seek to investigate the relationship between placental growth and serum levels of various biomarkers to see if improved detection of adverse outcome can be achieved.
- Conditions
- Hypertension Induced by Pregnancy, Pre-Eclampsia, IUGR
- Medical subject headings
- Hypertension, Pregnancy-Induced, Pre-Eclampsia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| No treatment | Singleton pregnancies presenting to the Genetic Counselor for Sequential Screening prior to 14 weeks gestation. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Small for gestational birth weight (SGA-dichotomous)
Neonatal weight and length are recorded at birth. This information will be retrieved from the medical record post partum.
Measured: from 11-14 weeks in pregnancy until delivery (approximately 40 weeks)
Secondary outcomes (1)
Includes a composite adverse outcome defined by any of the following: SGA, pre-eclampsia, or perinatal death.
Information about pregnancy outcomes will be retrieved from the maternal and neonatal medical record post partum.
Measured: post partum
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Aug 2012 (estimated)
- Study startNov 2009
- Primary completionJun 2016
- Study completionJun 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hypertension Induced by PregnancyStudies of the same condition, open and under way.
- More trials run by University of PennsylvaniaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,043 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pennsylvania
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Nadav Schwartz, MD, Principal investigator, University of Pennsylvania
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01669525
- Sponsor's protocol ID
- 811129
- Status last verified
- Jul 2017
- First submitted
- 15 Aug 2012
- Last updated
- 18 Jul 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Placental Growth and Maternal Serum Biomarkers in the Prediction of Adverse Pregnancy Outcome
- ClinicalTrials.gov ID
- NCT01669525
- Acronym / sponsor ID
- 811129
- Conditions
- Hypertension Induced by Pregnancy, Pre-Eclampsia, IUGR
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,043 participants (actual)
- Lead sponsor
- University of PennsylvaniaUniversity, hospital or other
- Study start
- Nov 2009
- Primary completion
- Jun 2016 (actual)
- Study completion
- Jun 2016 (actual)
- First posted
- 21 Aug 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study to determine if measurement of maternal serum biomarkers and evaluation of the placenta by ultrasound can improve prediction of adverse pregnancy outcomes.
Detailed description
The placenta is known to play a vital role in maintaining a healthy pregnancy. Placental dysfunction is believed to be a driving factor in a variety of adverse obstetric outcomes, including fetal growth restriction and preeclampsia. Advances in 3D ultrasound have allowed for measurement of placental volumes during pregnancy. It may be that quantitative assessment of early placental growth can help identify pregnancies at risk for adverse outcome. Furthermore, various novel serum analytes have been proposed as predictors of adverse outcome. The investigators seek to prospectively measure placental volume and diameter at 11-14 weeks and 18-24 weeks to determine if placental growth can predict adverse outcome. In addition, the investigators seek to investigate the relationship between placental growth and serum levels of various biomarkers to see if improved detection of adverse outcome can be achieved.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| No treatment | – | –Singleton pregnancies presenting to the Genetic Counselor for Sequential Screening prior to 14 weeks gestation. |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Singleton pregnancies presenting for Sequential Screen prior to 14 weeks gestation
Key inclusion criteria (2 listed)
- All singleton gestations presenting for Sequential Screen testing at HUP
- patients competent to provide verbal informed consent
Key exclusion criteria (6 listed)
- Multiple gestations
- patients not competent to provide informed consent
- patients found to be too late for the Sequential Screen
- pregnancy losses 20 weeks gestation
- major fetal anomalies
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Small for gestational birth weight (SGA-dichotomous)
Time frame: from 11-14 weeks in pregnancy until delivery (approximately 40 weeks)
Neonatal weight and length are recorded at birth. This information will be retrieved from the medical record post partum.
1 secondary outcome
Includes a composite adverse outcome defined by any of the following: SGA, pre-eclampsia, or perinatal death.
Time frame: post partum
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jul 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nadav Schwartz, MD principal investigator
University of Pennsylvania
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hypertension Induced by Pregnancy and Pre-Eclampsia, run by University of Pennsylvania at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Jul 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Small for gestational birth weight (SGA-dichotomous) (time frame: from 11-14 weeks in pregnancy until delivery (approximately 40 weeks)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jul 2017.